Back to resultsEvaluation Interest of the Circulating Tumor DNA Dosage in Patient With Hepatic Metastatic Uveal Melanoma Candidate to Complete Resection (ct DNA R0)
Primary Purpose
Uveal Melanoma
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling
Sponsored by
About this trial
This is an interventional other trial for Uveal Melanoma focused on measuring Circulating tumor DNA
Eligibility Criteria
Inclusion Criteria:
- Aged 18 years old or more
- Patient with hepatic injury of metastatic uveal melanoma eligible for curative surgery (R0).
- No other distant metastasis (CT thoracic -abdomino -pelvic, bone scan).Measurable metastatic disease (echography, CT and/or MRI, FDG-PET, (fluoro- D-glucose integrated with computed tomography)).
- Patient able to stand a blood collection.
Patient explanation given and consent information signed or by legal representative.
Exclusion Criteria:
- Patient without social protection / insurance..
- Patient with hepatic metastasis unresectable by surgery
- Patient with extra-hepatic metastasis.
- Person deprived of liberty or under guardianship
- Inability to submit to medical monitoring of the trial for reasons of geography, social or psychological.
Sites / Locations
- Institut Curie
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Biological/Vaccine
Arm Description
Outcomes
Primary Outcome Measures
Correlation between the circulating tumor DNA rate before/after surgery and the rate of effective complete resection
Comparison the circulating tumor DNA rate before/after surgery and the rate of effective complete resection.
Secondary Outcome Measures
stability of the circulating tumor DNA on 2 pre-surgery samples
Comparison the circulating tumor DNA rate before/after surgery
Study of the correlation between the variation rate of the circulating tumor DNA at different points (T0, T1, T2, T3, T4 and Tn) and the apparition time of metastasis on hepatic MRI during the study follow-up.
Timepoints :
T0 and T1 : before surgery T2 : 2 days after surgery T3 : 8 days after surgery T4 to T9 : every 4 months up to two years.
Detection of GNA11 or GNAQ mutation on one of the hepatic metastasis
Search of GNA 11 or GNAQ mutation by Next Generation Sequencing techniques
Comparative study of the mutation profile of the ocular tumor if available, resected hepatic metastasis.
Histological study of the resected hepatic metastasis (inflammation, Ki 67, necrosis, fibrosis and vascularization, genomic analysis of the metastasis)
Detection of genetic factors for uveal melanoma
Search of genetic factors for uveal melanoma to be used as predictive evidence of the clinical response for possible future treatment
Study of overall survival after HMUM resection
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02849145
Brief Title
Evaluation Interest of the Circulating Tumor DNA Dosage in Patient With Hepatic Metastatic Uveal Melanoma Candidate to Complete Resection (ct DNA R0)
Official Title
Study to Evaluation Interest of the Circulating Tumor DNA Dosage in Patient With Hepatic Metastatic Uveal Melanoma Candidate to Complete Resection (R0)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
February 25, 2020 (Actual)
Study Completion Date
February 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prospective, open labelled, monocentric trial to evaluation of the circulating tumor DNA rate in the blood, before and after curative resection of hepatic metastasis of uveal melanoma (HMUM) and during post-surgery follow-up
Detailed Description
The ct DNA R0 study is a prospective, open labelled, monocentric trial. The aim is to evaluate the circulating tumor DNA rate in the blood, before and after curative resection of hepatic metastasis of uveal melanoma (HMUM) and during post-surgery follow-up.
The patient will have a blood sample before and after the surgery and during the post-surgery follow-up. The patient will have a maximum of 10 blood samples during the 2 years of his follow-up of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveal Melanoma
Keywords
Circulating tumor DNA
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biological/Vaccine
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Blood sampling
Intervention Description
7,5 ml of patient peripherical blood will be collected at each blood sample.
Primary Outcome Measure Information:
Title
Correlation between the circulating tumor DNA rate before/after surgery and the rate of effective complete resection
Description
Comparison the circulating tumor DNA rate before/after surgery and the rate of effective complete resection.
Time Frame
Up to one month
Secondary Outcome Measure Information:
Title
stability of the circulating tumor DNA on 2 pre-surgery samples
Description
Comparison the circulating tumor DNA rate before/after surgery
Time Frame
Up to one month
Title
Study of the correlation between the variation rate of the circulating tumor DNA at different points (T0, T1, T2, T3, T4 and Tn) and the apparition time of metastasis on hepatic MRI during the study follow-up.
Description
Timepoints :
T0 and T1 : before surgery T2 : 2 days after surgery T3 : 8 days after surgery T4 to T9 : every 4 months up to two years.
Time Frame
two years
Title
Detection of GNA11 or GNAQ mutation on one of the hepatic metastasis
Description
Search of GNA 11 or GNAQ mutation by Next Generation Sequencing techniques
Time Frame
Up to one month
Title
Comparative study of the mutation profile of the ocular tumor if available, resected hepatic metastasis.
Time Frame
Up to one month
Title
Histological study of the resected hepatic metastasis (inflammation, Ki 67, necrosis, fibrosis and vascularization, genomic analysis of the metastasis)
Time Frame
Up to one month
Title
Detection of genetic factors for uveal melanoma
Description
Search of genetic factors for uveal melanoma to be used as predictive evidence of the clinical response for possible future treatment
Time Frame
Up to one month
Title
Study of overall survival after HMUM resection
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18 years old or more
Patient with hepatic injury of metastatic uveal melanoma eligible for curative surgery (R0).
No other distant metastasis (CT thoracic -abdomino -pelvic, bone scan).Measurable metastatic disease (echography, CT and/or MRI, FDG-PET, (fluoro- D-glucose integrated with computed tomography)).
Patient able to stand a blood collection.
Patient explanation given and consent information signed or by legal representative.
Exclusion Criteria:
Patient without social protection / insurance..
Patient with hepatic metastasis unresectable by surgery
Patient with extra-hepatic metastasis.
Person deprived of liberty or under guardianship
Inability to submit to medical monitoring of the trial for reasons of geography, social or psychological.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascale Mariani, MD
Organizational Affiliation
Institut Curie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Evaluation Interest of the Circulating Tumor DNA Dosage in Patient With Hepatic Metastatic Uveal Melanoma Candidate to Complete Resection (ct DNA R0)
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